On January 23, 2023, EMA uploaded a factual report of the EU survey conducted from July 18, 2022, to September 19, 2022, to understand the issues encountered by the sponsors.
The survey consisted of questions related to the blocking issues faced in the submission of the clinical trials applications under the Clinical Trials Directive 2001/20/EC (CTD) instead of the Clinical Trials Regulation (EU) No 536/2014, harmonization of CTR in the conduct of clinical trials, obstacles in setting up multi-country clinical trials under the CTR, the safety of clinical trial participants in CTR, and inconsistency between CTR and other EU initiatives.
The responses of 62 sponsors and stakeholders, including any issues they faced, were submitted in the comments section. The majority of the comments pertained to:
- Inconsistencies between the ‘Guidance on deferrals’ for publication and CTIS
- Inconsistencies or lack of clarity between the CTR, the IVDR, the MDR
- Inconsistencies between ICH GCP and CTR
- Lack of clarity regarding the articulation of the CTR and EMA Policies 0043 and 0070
- Uncertainties regarding the assessment of redactions and deferrals.
- The management of third-country data for trials under Paediatric Investigation Plans once EudraCT is decommissioned.
- Requests for remediation process put in place to allow post-disclosure corrections in CTIS and information on the articulation of the MDR, IVDR, and the CTR
Solutions to most of the issues have already been provided through a number of CTIS updates. A CTIS release is planned at the end of January that will resolve the blocking issues. New functionalities will be developed in 2023 and 2024, along with further user experience improvements, considering the views expressed by all users, sponsors, national authorities, and ethics committees.
An updated Q&A document disseminating the main principles agreed on the protection of CCI and personal data will be published soon.